UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000035
Receipt number R000000062
Scientific Title A Randomized Phase III trial of chemotherapy alone versus chemotherapy followed by gefitinib in stage IIIB/IV non-small cell lung cancer
Date of disclosure of the study information 2005/09/04
Last modified on 2005/09/04 22:37:28

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Basic information

Public title

A Randomized Phase III trial of chemotherapy alone versus chemotherapy followed by gefitinib in stage IIIB/IV non-small cell lung cancer

Acronym

A Randomized Phase III trial of chemotherapy alone versus chemotherapy followed by gefitinib in stage IIIB/IV non-small cell lung cancer

Scientific Title

A Randomized Phase III trial of chemotherapy alone versus chemotherapy followed by gefitinib in stage IIIB/IV non-small cell lung cancer

Scientific Title:Acronym

A Randomized Phase III trial of chemotherapy alone versus chemotherapy followed by gefitinib in stage IIIB/IV non-small cell lung cancer

Region

Japan


Condition

Condition

Stage IIIB/IV Non-small cell lung cancer

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

A randomized phase III trial of platinum-based chemotherapy alone versus platinum-based chemotherapy followed by maintenance therapy with gefitinib in patients with stage IIIB/IV NSCLC.

Basic objectives2

Pharmacokinetics

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Overall survival

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Platinum doublet chemotherapy more than 3 cycles up to 6 cycles.

Interventions/Control_2

Platinum doublet chemotherapy 3 cycles followed by gefitinib except PD cases.

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

75 years-old >

Gender

Male and Female

Key inclusion criteria

Histologically or cytologically confirmed NSCLC
Stage IIIB/IV
No prior treatment
Measurable disease
ECOG PS 0-1
Adequate organ function
Age 20-74
Written informed consent

Key exclusion criteria

Pregnancy or breast feeding
Past history of drug hypersensitivity
SVC syndrome
Pleural or pericardial effusion that required drainage
Active infection
Interstitial pneumonia or active lung fibrosis
Symptomatic brain metastasis
Active concomitant malignancy
Uncontrolled diabetes
Uncontrolled heart disease

Target sample size

600


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toyoaki Hida

Organization

Aichi cancer center hospital

Division name

Department of Thoracic Oncology

Zip code


Address

1-1 Kanokoden, Chikusa-ku, Nagoya

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

West Japan Thoracic Oncology Group (WJTOG)

Division name

West Japan Thoracic Oncology Group (WJTOG)

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

West Japan Thoracic Oncology Group (WJTOG)

Institute

Department

Personal name



Funding Source

Organization

West Japan Thoracic Oncology Group (WJTOG)

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2005 Year 09 Month 04 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2003 Year 01 Month 20 Day

Date of IRB


Anticipated trial start date

2004 Year 04 Month 01 Day

Last follow-up date

2007 Year 05 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2005 Year 08 Month 02 Day

Last modified on

2005 Year 09 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000062


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name